study of nms-03592088 in patients with relapsed or refractory aml or cmml

Conditions: Acute Myeloid Leukemia (AML); Chronic Myelomonocytic Leukemia (CMML)

Summary: the purpose of this study is to explore safety, tolerability, including the maximum tolerated dose and the recommended phase ii dose (rp2d), and antitumor activity of nms-03592088 in adult patients with relapsed or refractory acute myeloid leukemia (aml) or chronic myelomonocytic leukemia (cmml).


Eligibility criteria:
inclusion criteria: * patients with relapsed/refractory disease who have failed standard therapy or are unsuitable for standard treatment, with one the following confirmed diagnosis: aml as defined by the european leukemianet (eln) * patients with confirmed diagnosis of aml as defined by the 2022 eln recommendations * patients must have failed standard of care. * adult (age ≥ 18 years) patients * eastern cooperative oncology group (ecog) performance status ≤ 2 * the interval from prior antitumor treatment to time of nms-03592088 administration should be at least 2 weeks for any agents other than hydroxyurea. * all acute toxic effects (excluding alopecia) of any prior therapy must have resolved to nci ctcae version 5.0 grade ≤1 * adequate hepatic and renal function * patients must use highly effective contraception. * signed and dated iec or irb-approved informed consent form. exclusion criteria: * current enrollment in another interventional clinical study * diagnosis of acute promyelocytic leukemia or breakpoint cluster region-abelson (bcr-abl)-positive leukaemia * currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or cone biopsied in situ carcinoma of the cervix uteri and/or superficial bladder cancer. * patients with known leukemia involvement of central nervous system (cns) * hematopoietic stem cell transplantation (hsct) within 3 months of treatment start and/or persistent non-hematologic toxicities of grade ≥2 related to the transplant * active acute or chronic graft versus host disease (gvhd) requiring immunosuppressive treatment * patients with qtcf interval ≥ 480 milliseconds or with risk factors for torsade de pointes * pregnancy. * breast-feeding or planning to breast feed during the study or within 3 months after study treatment. * any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * known active, life threatening or clinically significant uncontrolled systemic infection. * known active gastrointestinal disease * known active gastrointestinal ulcer * other severe or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation. * known diagnosis of myasthenia gravis us only: * signs or symptoms of myasthenia gravis or stroke during screening * patients with myasthenia gravis specific autoantibodies or any known history of myasthenia gravis (mg) autoantibodies at screening window * concomitant medications with the potential to cause de novo myasthenia gravis, worsening of myasthenia gravis or cause myasthenia gravis-like symptoms * uncontrolled hypertension, atrial fibrillation or flutter, ventricular arrhythmia or receiving treatment for cardiac rhythm disorder or diabetes that is not adequately controlled other protocol specific inclusion/exclusion criteria may apply